Sugammadex and Heart Failure
Primary Purpose
Postoperative Neuromuscular Block
Status
Completed
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
Sugammadex
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Neuromuscular Block focused on measuring antagonists neuromuscular block, neuromuscular block, monitoring, neuromuscular function
Eligibility Criteria
Inclusion Criteria:
- aged 18 yr or older
- categorized as American Society of Anesthesiologists class 3-4 and New York Heart Association class 2-4
- with an ejection fraction <25%
- scheduled to undergo elective surgery for cardiac resynchronization therapy, an automated implantable cardioverter-defibrillator (ICD), or battery replacement of an ICD or biventricular pacemaker, during general anaesthesia.
Exclusion Criteria:
- expected to have a difficult intubation for anatomic reasons
- they had a neuromuscular disorder
- a personal or family history of malignant hyperthermia
- or known allergy to medication used during general anaesthesia
- not able or willing to give written informed consent.
Sites / Locations
- OLV Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sugammadex
Arm Description
Outcomes
Primary Outcome Measures
The time from start of sugammadex administration to recovery of the train-of-four (TOF) ratio to 0.9.
Secondary Outcome Measures
The time from start of sugammadex administration to recovery of the TOF ratio to 0.7 and 0.8.
Adverse hemodynamic events.
Adverse respiratory events (SpO2 <90% and/or signs of airway obstruction).
Full Information
NCT ID
NCT01509651
First Posted
January 1, 2012
Last Updated
April 3, 2012
Sponsor
Onze Lieve Vrouw Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01509651
Brief Title
Sugammadex and Heart Failure
Official Title
Reversal of Rocuronium-induced Neuromuscular Block With Sugammadex in Heart Failure Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Onze Lieve Vrouw Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Although anticholinesterase reversal agents have been used in combination with anticholinergic drugs for over half a century, it has been suggested that they should be used with caution in patients with underlying cardiovascular disease. As sugammadex has no endogenous targets, it is unlikely to cause any adverse cardiovascular effects. This selective relaxant binding agent is specifically designed to encapsulate rocuronium, which can, therefore, promptly restore neuromuscular function regardless of any levels of NMB as the dose is increased.
Some reports, however, suggest that sugammadex may have increased time to effect in some patient populations like the elderly, patients in intensive care and renal failure patients. A less dynamic circulation and increased transfer time to the effector site in these subjects are likely explanations for this effect. The present trial was designed to assess the safety and efficacy of sugammadex 2.0 mg kg-1 for the reversal of rocuronium-induced NMB in patients with heart failure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Neuromuscular Block
Keywords
antagonists neuromuscular block, neuromuscular block, monitoring, neuromuscular function
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sugammadex
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Sugammadex
Intervention Description
After the induction of anaesthesia, monitoring neuromuscular function is initiated and performed continuously using the TOF-Watch SX (Organon Ireland Ltd, Ireland) at the thumb. Repetitive train-of four (TOF) stimulation is applied every 15 s at the ulnar nerve until the end of anaesthesia, at least until recovery of the TOF ratio to 0.9 after administration of sugammadex. Each patient receives a single IV bolus dose of rocuronium 0.6 mg kg-1, after which tracheal intubation is performed. Maintenance doses of rocuronium 0.1 mg kg-1, are permitted as required and administered at the reappearance of the second twitch in the TOF. On reappearance of the second twitch at the end of surgery, patients receive a single IV bolus dose of sugammadex, 2.0 mg kg-1, for reversal.
Primary Outcome Measure Information:
Title
The time from start of sugammadex administration to recovery of the train-of-four (TOF) ratio to 0.9.
Time Frame
Participants will be followed for the duration of recovery from neuromuscular block, an expected average of 10min
Secondary Outcome Measure Information:
Title
The time from start of sugammadex administration to recovery of the TOF ratio to 0.7 and 0.8.
Time Frame
Participants will be followed for the duration of recovery from neuromuscular block, an expected average of 10min
Title
Adverse hemodynamic events.
Time Frame
From anesthesia induction until 3h after arrival in the postanaesthesia care unit (PACU).
Title
Adverse respiratory events (SpO2 <90% and/or signs of airway obstruction).
Time Frame
From arrival in the PACU until 30min thereafter.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
aged 18 yr or older
categorized as American Society of Anesthesiologists class 3-4 and New York Heart Association class 2-4
with an ejection fraction <25%
scheduled to undergo elective surgery for cardiac resynchronization therapy, an automated implantable cardioverter-defibrillator (ICD), or battery replacement of an ICD or biventricular pacemaker, during general anaesthesia.
Exclusion Criteria:
expected to have a difficult intubation for anatomic reasons
they had a neuromuscular disorder
a personal or family history of malignant hyperthermia
or known allergy to medication used during general anaesthesia
not able or willing to give written informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guy Cammu, MD, PhD
Organizational Affiliation
OLV Hospital, Anesthesiology and CCM, Aalst, Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
OLV Hospital
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
16571960
Citation
Sorgenfrei IF, Norrild K, Larsen PB, Stensballe J, Ostergaard D, Prins ME, Viby-Mogensen J. Reversal of rocuronium-induced neuromuscular block by the selective relaxant binding agent sugammadex: a dose-finding and safety study. Anesthesiology. 2006 Apr;104(4):667-74. doi: 10.1097/00000542-200604000-00009.
Results Reference
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PubMed Identifier
19455040
Citation
Dahl V, Pendeville PE, Hollmann MW, Heier T, Abels EA, Blobner M. Safety and efficacy of sugammadex for the reversal of rocuronium-induced neuromuscular blockade in cardiac patients undergoing noncardiac surgery. Eur J Anaesthesiol. 2009 Oct;26(10):874-84. doi: 10.1097/EJA.0b013e32832c605b.
Results Reference
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PubMed Identifier
21531745
Citation
Suzuki T, Kitajima O, Ueda K, Kondo Y, Kato J, Ogawa S. Reversibility of rocuronium-induced profound neuromuscular block with sugammadex in younger and older patients. Br J Anaesth. 2011 Jun;106(6):823-6. doi: 10.1093/bja/aer098. Epub 2011 Apr 29.
Results Reference
background
PubMed Identifier
18653492
Citation
Staals LM, Snoeck MM, Driessen JJ, Flockton EA, Heeringa M, Hunter JM. Multicentre, parallel-group, comparative trial evaluating the efficacy and safety of sugammadex in patients with end-stage renal failure or normal renal function. Br J Anaesth. 2008 Oct;101(4):492-7. doi: 10.1093/bja/aen216. Epub 2008 Jul 23.
Results Reference
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Sugammadex and Heart Failure
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